Clinical Trials Resource Center

Breast Pain

May 16, 2005

Ascend Therapeutics presented positive results of a phase II trial of a topical gel formulation of 4- hydroxytamoxifen (4-OHT), for the treatment of menstrual-cycle related mastalgia, at the 53rd Annual Clinical Meeting of the American College of Obstetricians and Gynecologists. Data from the study indicated that the highest dose of the drug significantly reduced symptoms severity vs. placebo, as measured by primary Visual Analogue Scale score (-32.1 mm vs. -19.3 mm, respectively; p=0.034), and secondary physician global assessments of pain (OR, 0.32; p=0.01), tenderness (OR, 0.33; p=0.012), and nodularity (OR, 0.30; p=0.017), and patient assessment of pain (OR, 0.36; p=0.022). No disruptions of menstrual cycles or menses were noted over the course of treatment, and plasma hormone levels were unaffected. This randomized, double- blind, placebo-controlled, dose-ranging study enrolled 130 adult premenopausal women with a history of cyclic mastalgia, who received one of two doses of 4-OHT (2 mg once or twice daily) for 4 menstrual cycles.

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